BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8255859 · Received January 17, 2019

    Report

    Report Number
    3006948883-2018-00426
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 5, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141383. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF FOREIGN MATERIAL BEING REPORTED IN THIS BATCH OF INTIMA II. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALTHOUGH A PHOTO HAS BEEN SUBMITTED ILLUSTRATING THE COMPLICATIONS, WITHOUT THE AFFECTED SAMPLE OUR ENGINEERS WERE UNABLE TO DETERMINE THE IDENTITY OR ROOT CAUSE OF THE MATERIAL SEEN IN THE TUBING OF THE DEVICE. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER TUBING WALL COLOR OF A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS BLACK.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER TUBING WALL COLOR OF A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50146 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER DQO BD (SUZHOU) 8141383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other